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Submission Statistics

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FDA ESG 2012-2022 Total Submission Statistics
  2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Totals
AERS 717,345 876,475 1,026,314 1,321,114 1,533,378 1,698,094 2,118,827 2,160,020 2,224,503 2,287,430 758,137 16,721,637
CDER 107,681 124,232 139,322 159,515 165,932 189,141 221,471 236,584 259,284 283,135 95,544 1,981,841
CBER 6,927 8,412 9,506 11,294 20,278 52,197 56,044 70,900 74,545 716,525 273,460 1,300,088
CDRH 462,316 666,927 812,443 1,478,524 2,032,767 1,921,871 2,247,286 2,774,852 2,960,441 3,774,725 1,654,042 20,786,194
CVM 37,928 40,978 44,607 52,601 64,197 70,436 70,682 74,750 86,437 88,216 25,686 656,518
OC 64,285 65,430 68,171 60,943 56,517 71,545 77,353 76,549 73,369 58,843 22,024 695,029
CTP 642 1,237 324 734 612 23,984 19,142 3,698 10,563 5,096 1,000 67,032
ACA 62 207 195 212 228 218 236 271 288 233 279 2,429
GDUFA 2,771 2,926 3,547 2,906 1,644 1,600 1,455 1,305 1,249 839 96 20,338
CFSAN 458 4,220 2,756 3,761 3,619 2,661 2,421 2,261 2,160 2,540 711 27,568
HC   324 5,835 9,366 16,497 23,595 26,927 27,302 35,167 40,392 12,691 198,096
ORA                   57 5 62
Totals 1,400,415 1,791,368 2,113,020 3,100,970 3,895,669 4,055,342 4,841,844 5,428,492 5,728,006 7,258,031 2,843,675 42,456,832
 
FDA ESG 2022 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 194,547 183,842 202,537 177,211                 758,137
CDER 21,590 24,083 26,823 23,048                 95,544
CBER 73,087 75,334 68,794 56,245                 273,460
CDRH 390,175 324,906 483,936 455,025                 1,654,042
CVM 5,693 5,721 7,448 6,824                 25,686
OC 7,106 5,766 4,372 4,780                 22,024
CTP 177 267 349 207                 1,000
ACA 3 16 240 20                 279
GDUFA 15 11 48 22                 96
CFSAN 156 170 218 167                 711
HC 3,010 3,015 3,614 3,052                 12,691
ORA 0 1 2 2                 5
Totals 695,559 623,132 798,381 726,603                 2,843,675
FDA ESG 2022 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 194,547 183,842 202,537 177,211                 758,137
CDER 43,180 48,166 53,646 46,096                 191,088
CBER 146,174 150,668 137,588 112,490                 546,920
CDRH 1,170,525 974,718 1,451,808 1,365,075                 4,962,126
CVM 11,386 11,442 14,896 13,648                 51,372
OC 14,212 11,532 8,744 9,560                 44,048
CTP 354 534 698 414                 2,000
ACA 6 32 480 40                 558
GDUFA 30 22 96 44                 192
CFSAN 156 170 218 167                 711
HC 6,020 6,030 7,228 6,104                 25,382
ORA 0 1 2 2                 5
Totals 1,586,590 1,387,157 1,877,941 1,730,851                 6,582,539

FDA ESG 2022 Monthly Total Traffic Statistics

  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 389,094 367,684 405,074 354,422                 1,516,274
CDER 64,770 72,249 80,469 69,144                 286,632
CBER 219,261 226,002 206,382 168,735                 820,380
CDRH 1,560,700 1,299,624 1,935,744 1,820,100                 6,616,168
CVM 17,079 17,163 22,344 20,472                 77,058
OC 21,318 17,298 13,116 14,340                 66,072
CTP 531 801 1,047 621                 3,000
ACA 9 48 720 60                 837
GDUFA 45 33 144 66                 288
CFSAN 312 340 436 334                 1,422
HC 9,030 9,045 10,842 9,156                 38,073
ORA 0 2 4 4                 10
Totals 2,282,149 2,010,289 2,676,322 2,457,454                 9,426,214

FDA ESG 2021 Monthly Submission Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 182,833 185,634 198,270 183,702 200,409 184,877 219,943 193,590 191,144 169,348 175,952 201,728 2,287,430
CDER 19,068 20,894 24,711 23,577 23,440 24,812 23,754 23,795 24,783 25,164 24,230 24,907 283,135
CBER 18,930 26,675 31,183 46,014 46,600 56,094 71,441 137,355 75,191 66,984 65,970 74,088 716,525
CDRH 323,386 252,371 332,767 288,054 269,252 324,867 339,939 381,403 268,729 323,952 319,559 350,446 3,774,725
CVM 5,910 5,890 7,728 6,752 7,498 8,592 7,783 8,526 7,330 7,676 7,988 6,543 88,216
OC 5,649 4,004 5,004 4,988 3,856 4,794 4,389 3,802 3,529 5,792 5,870 7,166 58,843
CTP 420 498 523 334 375 691 484 432 644 252 246 197 5,096
ACA 6 23 158 19 5 1 1 7 1 2 5 5 233
GDUFA 19 21 25 32 263 92 33 23 18 25 25 263 839
CFSAN 175 190 211 248 196 254 213 215 191 247 231 169 2,540
HC 3,157 3,259 3,869 3,236 3,231 3,619 3,589 3,310 3,257 3,308 3,344 3,213 40,392
ORA       3 5 3 15 9 1 9 8 4 57
Totals 559,553 499,459 604,449 556,959 555,130 608,696 671,584 752,467 574,818 602,759 603,428 668,729 7,258,031
FDA ESG 2021 Monthly Acknowledgement Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 182,833 185,634 198,270 183,702 200,409 184,877 219,943 193,590 191,144 169,348 175,952 201,728 2,287,430
CDER 38,136 41,788 49,422 47,154 46,880 49,624 47,508 47,590 49,566 50,328 48,460 49,814 566,270
CBER 37,860 53,350 62,366 92,028 93,200 112,188 142,882 274,710 150,382 133,968 131,940 148,176 1,433,050
CDRH 970,158 757,113 998,301 864,162 807,756 974,601 1,019,817 1,144,209 806,187 971,856 958,677 1,051,338 11,324,175
CVM 11,820 11,780 15,456 13,504 14,996 17,184 15,566 17,052 14,660 15,352 15,976 13,086 176,432
OC 11,298 8,008 10,008 9,976 7,712 9,588 8,778 7,604 7,058 11,584 11,740 14,332 117,686
CTP 840 996 1,046 668 750 1,382 968 864 1,288 504 492 394 10,192
ACA 12 46 316 38 10 2 2 14 2 4 10 10 466
GDUFA 38 42 50 64 526 184 66 46 36 50 50 526 1,678
CFSAN 175 190 211 248 196 254 213 215 191 247 231 169 2,540
HC 6,314 6,518 7,738 6,472 6,462 7,238 7,178 6,620 382 494 462 338 56,216
ORA       3 5 3 15 9 1 9 8 4 57
Totals 1,259,484 1,065,465 1,339,526 1,218,019 1,178,902 1,357,125 1,462,936 1,692,523 1,220,897 1,353,744 1,343,998 1,479,915 15,972,534
FDA ESG 2021 Monthly Total Traffic Statistics
  Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Totals
AERS 365,666 371,268 396,540 367,404 400,818 369,754 439,886 387,180 382,288 338,696 351,904 403,456 4,574,860
CDER 57,204 62,682 74,133 70,731 70,320 74,436 71,262 71,385 74,349 75,492 72,690 74,721 849,405
CBER 56,790 80,025 93,549 138,042 139,800 168,282 214,323 412,065 225,573 200,952 197,910 222,264 2,149,575
CDRH 1,293,544 1,009,484 1,331,068 1,152,216 1,077,008 1,299,468 1,359,756 1,525,612 1,074,916 1,295,808 1,278,236 1,401,784 15,098,900
CVM 17,730 17,670 23,184 20,256 22,494 25,776 23,349 25,578 21,990 23,028 23,964 19,629 264,648
OC 16,947 12,012 15,012 14,964 11,568 14,382 13,167 11,406 10,587 17,376 17,610 21,498 176,529
CTP 1,260 1,494 1,569 1,002 1,125 2,073 1,452 1,296 1,932 756 738 591 15,288
ACA 18 69 474 57 15 3 3 21 3 6 15 15 699
GDUFA 57 63 75 96 789 276 99 69 54 75 75 789 2,517
CFSAN 350 380 422 496 392 508 426 430 382 494 462 338 5,080
HC 9,471 9,777 11,607 9,708 9,693 10,857 10,767 9,930 573 741 693 507 84,324
ORA       6 10 6 30 18 2 18 16 8 114
Totals 1,819,037 1,564,924 1,943,975 1,774,978 1,734,032 1,965,821 2,134,520 2,444,990 1,792,649 1,953,442 1,944,313 2,145,600 23,218,281
 

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